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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW ARROW MAC DOUBLE LUMEN CATHETER

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ARROW ARROW MAC DOUBLE LUMEN CATHETER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Low Blood Pressure/ Hypotension (1914); Rash (2033); Tachycardia (2095)
Event Date 01/04/2017
Event Type  Injury  
Event Description
Patient presented for mini mr, pmh severe mr, mvp, mild asthma, htn, hld, nstemi in 2012, nkda, latex allergic, anesthesia induction/intubation without incident. A 9f double lumen catheter inserted in rij, with quick hypotension, tachycardia, facial rash. Catheter removed, treated with epinephrine, vasopressin, benadryl, hydrocortisone. Tryptase elevated. Case cancelled. Catheter checked- latex free. +chg coated, silver sulfadine.
 
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Brand NameARROW
Type of DeviceMAC DOUBLE LUMEN CATHETER
Manufacturer (Section D)
ARROW
MDR Report Key6307715
MDR Text Key66811372
Report NumberMW5067711
Device Sequence Number1
Product Code FOZ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 02/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 02/03/2017 Patient Sequence Number: 1
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